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中文(ZH) 赛升药业:达格列净片药品注册上市许可申请获受理

Chinese pharma subsidiary gets drug approval in China, another subsidiary gets FDA approval for insulin

Sai Sheng Pharmaceutical's subsidiary, Saier Biological, has received acceptance for its Dagliflozin Tablets drug registration and marketing license application from China's National Medical Products Administration. This medication works by reducing blood sugar through inhibiting renal glucose reabsorption, offering a low risk of hypoglycemia, no weight gain, and mild gastrointestinal side effects. Separately, Jianyou Co., Ltd.'s subsidiary, Emerge Bioscience Pte. Ltd., has obtained approval from the U.S. FDA for its Insulin Aspart Injection BLA, which is used to improve glycemic control in adult and pediatric diabetes patients. AI

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Chinese pharma subsidiary gets drug approval in China, another subsidiary gets FDA approval for insulin

COVERAGE [1]

  1. 36氪 (36Kr) TIER_1 中文(ZH) ·

    SaiSheng Pharmaceutical: Dapagliflozin Tablets Drug Registration Marketing Authorization Application Accepted

    36氪获悉,赛升药业公告,子公司赛而生物近日收到国家药监局下发的达格列净片境内生产药品注册上市许可申请的《受理通知书》。该药品通过抑制肾小管葡萄糖重吸收、促进尿糖排泄来降低血糖,单药使用低血糖风险低,不引起体重增加,胃肠道反应轻微,并可能通过减轻糖毒性而保护胰岛β细胞功能。